U.S. Calls for Pause of J&J (JNJ) Vaccine After Clotting Cases, Including One Death

April 13, 2021 7:00 AM EDT

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(Updated - April 13, 2021 7:06 AM EDT)

The FDA and CDC on Tuesday called for an immediate pause in the use of J&J's (NYSE: JNJ) coronavirus vaccine after six recipients in the U.S. developed a rare disorder involving blood clots within about two weeks of vaccination.

All six recipients were women between ages 18 to 48. One woman died and a second woman has been hospitalized in critical condition.

"Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC said in a statement.

The FDA called the adverse events "extremely rare", with more than 6.8 million doses of the J&J vaccine administered in the U.S. as of 04/12.

"COVID19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously," the FDA added.

The FDA will host a press conference at 10 a.m. EDT.



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